cdc-rfa-ck17-1701 - amendment ii 05 05 16.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Emerging Infections Programs

CDC-RFA-CK17-1701

Application Due Date: 06/30/2016

Emerging Infections Programs

CDC-RFA-CK17-1701

TABLE OF CONTENTS

Part I. Overview Information Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Application and Submission Information D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-CK17-1701. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry

(ATSDR)

B. Funding Opportunity Title:

Emerging Infections Programs C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc. gov/od/ science/ integrity/ docs/cdc- policy- distinguishing- public- health- research- nonresearch. pdf.

Disregard above statement that announcement is only for non-research activities. Research activities are allowable and fundable under this FOA. Note research and human subjects protection guidance inserted throughout this FOA.

FOA AMENDED to increase Application Narrative page limit to 75 (see FOA Part II, Section D.10. - "Project Narrative."

D. Agency Funding Opportunity Number:

CDC-RFA-CK17-1701

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.317 F. Dates:

1. Due Date for Letter of Intent (LOI): 05/06/2016

2. Due Date for Applications: 06/30/2016, 11:59 p.m. U.S.

Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

Webinar Info:

Friday - April 29, 2016 from 1:00 - 2:30PM EST

Web link: https://webconf.cdc.gov/skm5/696HGJD7

Audio Call-in: 888-324-6989 Participant Passcode: 2825114

G. Executive Summary:

1. Summary Paragraph:

The purpose of this FOA is to sustain and enhance the existing Emerging Infections Program (EIP) https://foa.grantsolutions.gov/announcementmodule/www.grants.gov https://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov https://webconf.cdc.gov/skm5/696HGJD7

The purpose of this FOA is to sustain and enhance the existing Emerging Infections Program (EIP) network. Activities of the EIPs fall into the following overall categories: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies and newly emerging issues. The EIP network is particularly suited to address key public health issues and inform public health policy and treatment guidelines, focusing on priority activities that lead directly to the prevention of disease.

Specifically, this FOA addresses the following EIP activities: Active Bacterial Core Surveillance (ABCs), Foodborne Disease Active Surveillance Network (FoodNet), Influenza, Healthcare Associated Infections and Antimicrobial Resistance, Human Papilloma Virus IMPACT, Lyme and Other Tickborne Diseases (TickNET), Rotavirus, Prion Disease, Arbovirus, Congenital Cytomegalovirus, and other applicant-specific activities.

a. Eligible Applicants: Limited

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 10

d. Total Project Period Funding: $175,000,000

e. Average One Year Award Amount: $3,500,000

f. Total Project Period Length: 5

g. Estimated Award Date: 12/01/2016

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview The Emerging Infections Program (EIP) was initiated in 1995 in response to the growing concern over the emergence and re-emergence of infectious diseases. Following the 1992 Institute of Medicine report “Emerging Infections: Microbial Threats to the United States,” CDC developed and published in 1994 a plan for addressing these threats. That plan highlighted the foundational role of surveillance and included in its recommendations, the creation of a network of population-based centers of excellence established through state public health departments collaborating with academic institutions, local health departments, public health and clinical laboratories, infection control professionals, healthcare providers, and CDC for special surveillance and applied public health research - the EIP. See CDC’s EIP website at http://www.cdc.gov /ncezid/dpei/eip.

The EIP can be better understood through the metaphor of a tree with roots, a trunk, and branches. The roots are the recognition and documentation of the growing problem and the recommendations in the above cited reports. The trunk is the crosscutting capacity and functionality needed to sustain the network and ensure it can adapt (the General EIP Function and Structure activity described in Attachment 1), while the branches are disease area-specific activities (also described in Attachment 1). See this clearly illustrated in a recent Emerging Infectious Diseases journal article at http://wwwnc.cdc.gov/eid/article/21/9/15-0619.

EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases. Activities of the EIPs fall into the following overall categories: (1) active surveillance;

http://wwwlink.cdc.gov/ncezid/dpei/eip http://wwwlink.cdc.gov/ncezid/dpei/eip http://wwwnc.cdc.gov/eid/article/21/9/15-0619

(2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies and newly emerging issues. The EIP network is particularly suited to address key public health issues and inform public health policy and treatment guidelines, focusing on priority activities that lead directly to the prevention of disease.

Over the past 20+ years, the EIPs have proved to be a national resource for conducting active, population-based surveillance and special studies for invasive bacterial diseases including antibiotic-resistant infections, foodborne pathogens, healthcare associated infections (HAIs), influenza, and many other infectious diseases.

For additional background information, see the individual EIP activity descriptions in Attachment 1 – Activities.

b. Statutory Authorities This program is authorized under the Public Health Service Act Sections 301(a)[42 U.S.C. 241(a)], 317(k)(1)[42 U.S.C. 247b(k)(1), and 317(k)(2)[42 U.S.C. 247b(k)(2)], as amended.

c. Healthy People 2020 This program addresses the “Healthy People 2020” focus area(s) of Food Safety, Healthcare-Associated Infections, Immunizations and Infectious Diseases, Public Health Infrastructure, and Respiratory Diseases.

http://www.healthypeople.gov

d. Other National Public Health Priorities and Strategies This FOA supports various national public health strategies/priorities for infectious diseases and other conditions. See Attachment 1 – Activities, for specific information regarding national priorities and strategies for each individual EIP activity.

e. Relevant Work EIP has been in existence since 1995. There are currently 10 grantees in the EIP that are completing their most recent 5-year EIP project period (1/1/2012 – 12/31/2016). See http://www.cdc.gov/ncezid/dpei/eip for details of the relevant work.

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

Strategies and Activities Short-Term Outcomes Long-Term Outcomes

- Population-based approach

- Crosscutting scientific and business support

- Flexibility to address emerging/urgent issues

- Partnerships and collaborative network

- Training

- More and improved data for informing public health policy available

- Novel/improved surveillance methods developed and implemented

- Baseline incidence/prevalence of infectious diseases and other conditions established

- Risk factors for infectious diseases and other conditions established

- Trends in infectious diseases and other conditions, including antimicrobial resistance,

- Improved public health system surveillance and response capacity

- Public health system better informed, prepared, and able to identify, control, mitigate, and prevent outbreaks of infectious diseases and other conditions http://www.healthypeople.gov http://wwwlink.cdc.gov/ncezid/dpei/eip

- Data management and information dissemination

- Information systems and standardized data collection and transmission

- Laboratory specimen collection and banking

- Active surveillance, applied public health epidemiologic and laboratory activities and research, prevention/intervention evaluation conditions, including antimicrobial resistance, identified

- Interventions with established effectiveness developed and available

- New/updated disease treatment guidelines and interventions with established effectiveness developed and available

- High-risk populations for various infectious diseases and other conditions identified

- Decreased incidence and severity of infectious diseases and other conditions

i. Purpose The purpose of this program announcement is to sustain and enhance support to the existing EIP network and potentially develop new sites as part of the EIP.

Specific purpose and objectives of each EIP activity (listed in Section 2.a.3 – “Strategies and Activities,” below) are included in Attachment 1 - Activities.

ii. Outcomes The overall outcomes will focus on:

More and improved data for informing public health policy available Novel/improved surveillance methods developed and implemented Baseline incidence/prevalence of infectious diseases and other conditions established Risk factors for infectious diseases and other conditions established Trends in infectious diseases and other conditions, including antimicrobial resistance, identified Interventions with established effectiveness developed and available New/updated disease treatment guidelines and interventions with established effectiveness developed and available High-risk populations for various infectious diseases and other conditions identified

For details regarding the expected outcomes of each EIP activity, refer to Attachment 1 - Activities.

Awardees will be held accountable for meeting the project period outcomes included in Attachment 1.

iii. Strategies and Activities EIP activities include general crosscutting function and structure as well as individual programmatic activities. Some activities are required (all applicants must apply) and some are optional.

Following is a brief overview of each EIP activity. Details for each EIP activity are provided in Attachment 1 - Activities. Awardees will be held accountable for all requirements included in Attachment 1 for each Activity for which they are funded.

General EIP Function and Structure: Attachment 1, Section A - Required

Population-based Activities: Identify and manage populations/catchment areas for EIP activities as appropriate.

1.

appropriate.

Management and Coordination: Ensure sufficient scientific, programmatic, and business/administrative leadership, management, and coordination of the EIP.

2.

Flexibility: Ensure flexibility and efficiency of the EIP to respond to emerging or urgent public health issues.

3.

Collaboration and Partnerships: Develop and operate the EIP site to function effectively as a member of the national network and establish partnerships with an academic institution (required) and other local partners (optional as appropriate for various programmatic activities).

4.

Training: Incorporate training in the EIP. 5.

Data Management: Collect, manage, analyze, and interpret data from EIP projects. Work with CDC to develop Data Management Plans for any funded activities and to assure adherence to CDC’s policies regarding public health research and non-research data management and access.

6.

Information Systems: Improve and modernize information systems and adopt and take advantage of electronic data exchange.

7.

Lab Specimens: Ensure availability of lab specimens/clinical isolates.8.

Program Evaluation: Assure capacity for EIP program evaluation and performance measurement.9.

Human and Vertebrate Animal Subjects Protections, Paperwork Reduction Act, and Dual Use Research of Concern: Ensure adherence to human and vertebrate animal subjects protection policies and requirements. Work with CDC scientists to obtain Office of Management and Budget Paperwork Reduction Act (OMB-PRA) approvals, as needed. Comply with the United States Government Policy for Institutional Oversight of Life Science Dual Use Research of Concern (DURC).

10.

Programmatic Activities:

Core Programmatic Network Activities (Each includes required and optional activities)1.

Active Bacterial Core surveillance (ABCs): Attachment 1, Section B Active, laboratory, population-based surveillance and conduct special studies for invasive group A Streptococcus, H. influenzae, N.meningitidis, group B Streptococcus, and S. pneumoniae in order to monitor their disease burden, track antimicrobial resistance and evaluate prevention strategies. Enhanced pertussis and legionellosis surveillance and special studies will be done to better understand rising disease rates and evaluate prevention strategies to reverse these rising trends.

Foodborne Diseases Active Surveillance Network (FoodNet): Attachment 1, Section C Active, population-based surveillance at select US sites for laboratory-confirmed infections of 9 bacterial and parasitic pathogens transmitted commonly through food (Campylobacter, Cyclospora, Cryptosporidium, Listeria monocytogenes, Salmonella, Shiga toxin-producing Escherichia coli (STEC), Shigella, Vibrio, and Yersinia). FoodNet also conducts active surveillance for pediatric cases of Hemolytic Uremic Syndrome (HUS).

Influenza: Attachment 1, Section D Population-based surveillance to provide near real-time weekly rates of laboratory-confirmed influenza-associated hospitalizations during each influenza season. Special studies will be conducted to better understand laboratory practices and evaluate prevention strategies in high-risk populations.

Healthcare-Associated Infections and Antimicrobial Resistance: Attachment 1, Section E Population-based surveillance for specific HAI and/or AR pathogens or infections and special projects, including HAI and antimicrobial use prevalence surveys.

2. Other Programmatic Activities – All are optional

HPV-IMPACT: Attachment 1, Section F Evaluate the impact of the Human Papilloma Virus (HPV) vaccination program and evaluate vaccine effectiveness through a population-based surveillance system that could, in addition to monitoring overall CIN2+ trends, enable monitoring trends in HPV type distribution in CIN2+ lesions among vaccinated and unvaccinated women. Optional projects may also address other HPV-associated outcomes.

Lyme and Other Tickborne Diseases (TickNET): Attachment 1, Section G Better define the public health and economic burden of tickborne diseases in the United States, identify new risk factors, and develop and evaluate effective public health prevention and control strategies.

Rotavirus: Attachment 1, Section H Study the vaccine take of oral rotavirus vaccine in U.S. infants and assess for correlation of the vaccine response with the secretor phenotype and genotype status of the infants.

Prion Disease: Attachment 1, Section I Implement and maintain an active prion surveillance system in the U.S.

Arbovirus: Attachment 1, Section J Studies to better define the public health and economic burden of arboviral diseases in the United States, and to identify and improve public health prevention and control measures.

Congenital CMV: Attachment 1, Section K Establish the clinical sensitivity of dried blood spots for detection of congenital in newborns.

Other emerging or site-specific activities:

Applicants may propose individual projects that address emerging issues (e.g., respiratory syncytial virus, Legionnaire’s disease) and/or locally relevant public health issues that meet the objectives of the EIP. These may include activities addressing non-communicable diseases that have the potential to benefit from EIP abilities and approach.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

Awardees are expected to collaborate with CDC programs involved in EIP activities and other EIP grantees as described in the General EIP Function and Structure section, above, and in Application Content and individual program activity sections of Attachment 1. Awardees will be held accountable for meeting the collaboration requirements included in Attachment 1 - Activities.

b. With organizations not funded by CDC:

Awardees are required to collaborate with academic institutions and other partners as described in the General EIP Function and Structure section, above, and in Application Content and individual program activity sections of Attachment 1. Awardees will be held accountable for meeting the collaboration requirements included in Attachment 1 - Activities.

2. Target Populations See individual program activity sections of Attachment 1 for any applicable guidance regarding identifying populations, etc., for the individual activities. Overall and as appropriate, consider disparities based on race, ethnicity, gender identity, sexual orientation, geography, socioeconomic status, disability status, primary language, health literacy, and other relevant dimensions. Awardees will be held accountable for meeting any target population requirements included in Attachment 1 - Activities.

a. Inclusion See individual program activity sections of Attachment 1 for any applicable guidance regarding identifying

See individual program activity sections of Attachment 1 for any applicable guidance regarding identifying populations, etc., for the individual activities. Overall and as appropriate for the EIP activity, strive to include people with disabilities; tribal populations; non-English speaking populations; lesbian, gay, bisexual, and transgender (LGBT) populations; people with limited health literacy; and/or populations that may otherwise be overlooked by the program. Awardees will be held accountable for meeting any inclusion requirements included in Attachment 1 - Activities.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy For details regarding each EIP activity’s evaluation and performance measurement requirements, refer to each activity section of Attachment 1. Awardees will be held accountable for the requirements included in Attachment 1.

Generally, evaluation and performance measurement for the various EIP activities include quantitative and qualitative measures regarding the following:

Staff participation on EIP Steering Group meetings and calls and for individual EIP activity workgroup/committee meetings, calls, trainings, etc.

For surveillance, engagement of applicable partner institutions (clinical institutions, etc) For studies, enrollment of subjects/cases Completeness of data Quality of data Timeliness of data submission Collection and shipping of isolates Adherence to study/project protocols

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant).

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Awardees will be required to submit a more detailed Evaluation and Performance Measurement plan within the first 6 months of award, as described in the Reporting Section of this FOA.

Applicants are to develop evaluation and performance measurement plans in each of the separate application

Applicants are to develop evaluation and performance measurement plans in each of the separate application narratives (General EIP Function and Structure, Core Programmatic Network Activities, and Other Programmatic Activities). Detailed application instructions are provided in FOA Section D, below.

c. Organizational Capacity of Awardees to Implement the Approach The “ideal” applicant will have the superior organizational capacity needed to perform as an EIP, such as:

Strong program planning, program evaluation, performance monitoring, financial reporting, budget management and administration, personnel management.

Demonstrated relevant experience and capacity (management, administrative, and scientific/technical) to implement the activities and achieve the project outcomes, experience and capacity to implement the evaluation plan, and a staffing plan and project management structure sufficient to achieve the project outcomes and which clearly defines staff roles.

Existing working relationships with an academic partner (required) and possibly other institutions/organizations which can serve as a solid starting point for the EIP-specific partnerships necessary to successfully implement the EIP.

d. Work Plan In the application narrative, applicants must provide a detailed work plan for each individual activity (General EIP Function and Structure, Core Programmatic Network Activities, and Other Programmatic Activities) for the first year of the project and a high-level work plan for subsequent years. See application guidance/instructions in Application Content, below, and the individual activity sections of Attachment 1.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that awardees are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with awardees on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Other activities deemed necessary to monitor the award, if applicable.

These activities may include monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE

AGREEMENTS)

In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond

In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities

Provide general coordination for all EIP sites and the overall network.

Provide coordination specifically for EIP crosscutting activities such as information technology, quality assurance, culture-independent diagnostic testing, advanced molecular detection, etc.

Develop, facilitate, and participate in collaborative multi-site relationships as needed to support the successful completion of the project.

Provide consultation and scientific and technical assistance as necessary in the operation of the EIP. This may include:

Facilitating the development of protocols and procedure manuals, Assisting sites with local human subjects requirements, Training grantee personnel, Designing projects, Serotyping isolates, Performing antimicrobial susceptibility testing, Developing Data Management Plans, Analyzing and interpreting data, Disseminating results, Coordinating and facilitating communications among EIPs, and Facilitating and coordinating the development of information exchange. CDC will consult with sites to assist evolution of EIP-related information systems to conform with applicable (e.g., HHS, CDC) standards.

Obtain determination of research or non-research from the Associate Director for Science for the respective CIO when CDC scientists are engaged in the research.

Obtain IRB approval from the CDC Institutional Review Board for research involving human subjects when CDC is engaged.

Obtain Office of Management and Budget approval per the Paperwork Reduction Act, if necessary.

Assist grantee principal investigators, as needed, in complying with their responsibilities described in the United States Government Policy for Institutional Oversight of Life Science Dual Use Research of Concern (DURC) http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program

Support to Awardees Section.

2. Award Mechanism: U50

3. Fiscal Year: 2017

4. Approximate Total Fiscal Year Funding:

$35,000,000

5. Approximate Project Period Funding:

$175,000,000

This amount is subject to the availability of funds.

Estimated Total Funding: $175,000,000

6. Total Project Period Length:

5 year(s) http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf

7. Expected Number of Awards:

8. Approximate Average Award:

$3,500,000 Per Budget Period

9. Award Ceiling: $0 Per Budget Period

This amount is subject to the availability of funds.

No ceiling

10. Award Floor: $0 Per Budget Period No floor

11. Estimated Award Date: 12/01/2016

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this FOA.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

Additional Eligibility Category:

Government Organizations:

State governments or their bona fide agents (includes the District of Columbia)

2. Additional Information on Eligibility

Eligible applicants that can apply for this funding opportunity are listed below:

State governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with “Other Attachment Forms” when submitting via www.grants.gov.

3. Justification for Less than Maximum Competition Eligibility is limited to state health departments because the EIP infrastructure depends on a direct relationship with public health agencies that have sufficient legal authority and responsibility to perform public health surveillance and response activities. The network must also consist of definitive populations large enough to adequately determine disease burden, evaluate large scale interventions, and impact public health policy decisions. This is the same eligibility that has been a requirement of EIP since the program began in 1995.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement:

No

Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

5. Maintenance of Effort Maintenance of effort is not required for this program.

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/webform/ displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-awardees, those sub-awardees must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as an awardee. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC.

If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the “Get Registered” option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process usually takes http://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/portal/public/SAM/ http://grants.gov/ http://www.grants.gov/ http://www.grants.gov/ http://www.grants.gov/ not more than five days to complete. Applicants should start the registration process as early as possible.

Step System Requirements Duration Follow Up

1 Data Universal Number System

(DUNS)

1. Click on http://fedgov.dnb.com/webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http://fedgov.dnb.com/webform) or call 1-866-705-5711

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CRR)

1. Retrieve organizations DUNS number

2. Go to www.sam.gov and designate an E-Biz POC (note CCR username will not not work in SAM and you will need to have an active SAM account before you can register on grants.gov)

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fsd.gov/fsd-gov/home.do Calls:

866-606-8220

3 Grants.gov 1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative (AOR)

2. Once the account is set up the E-BIZ POC will be notified via email

3. Log into grants.gov using the password the E-BIZ POC received and create new password

4. This authorizes the AOR to submit applications on behalf of the organization

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants

MUST

obtain a

DUNS

number and SAM account before applying on grants.gov)

Register early! Log into grants.gov and check AOR status until it shows you have been approved

2. Request Application Package Applicants may access the application package at www.grants.gov.

http://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://www.sam.gov https://fsd.gov/fsd-gov/home.do

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunity at www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC OGS staff at 770-488-2700 or e-mail OGS ogstims@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

4. Submission Dates and Times If the application is not submitted by the deadline published in the FOA, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline.

The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: 05/06/2016

b. Application Deadline Due Date for Applications: 06/30/2016, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Date for Information Conference Call

Webinar Info:

Friday - April 29, 2016 from 1:00 - 2:30PM EST

Web link: https://webconf.cdc.gov/skm5/696HGJD7

Audio Call-in: 888-324-6989 Participant Passcode: 2825114

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent Due Date for Letter of Intent: May 6, 2016 http://www.grants.gov https://foa.grantsolutions.gov/announcementmodule/PGOTIM@cdc.gov%20 http://www.grants.gov https://webconf.cdc.gov/skm5/696HGJD7 http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx

Due Date for Letter of Intent: May 6, 2016

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed above, prospective applicants are asked to submit a letter of intent that includes the following information:

Number and title of this funding opportunity Descriptive title of any proposed research projects Name of applicant (health department and, if applicable, bona fide agent). If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state as documentation of your status at the time of application.

Name, address, email, and telephone number of the Principal Investigator/Project Director Names of other key personnel Participating academic institution(s) and other key partners

The letter of intent should be sent to:

Gregory Anderson, MS, MPH

Extramural Research Program Office

Office of the Associate Director for Science

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Road, MS E-60

Atlanta, GA 30333

Telephone: 404-718-8833

Fax: 404-718-8822

Email: GAnderson@cdc.gov

8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package.

Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other Attachment Forms" at www.grants.gov.

9. Project Abstract Summary (Maximum 1 page) A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov.

The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

mailto:GAnderson@cdc.gov http://www.grants.gov

10. Project Narrative (Maximum of 20 pages, single spaced, 12 point font, 1-inch margins, number all pages. Content beyond 20 pages will not be reviewed. The 20 page limit includes the work plan.)

Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov. The Project Narrative must include all of the bolded headings shown in this section. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and activities to be conducted over the entire project period as identified in the CDC Project Description section. Failure to follow the guidance and format may negatively impact scoring of the application.

a. Background Applicants must provide a description of relevant background information that includes the context of the problem (See CDC Background).

b. Approach

i. Purpose Applicants must describe in 2-3 sentences specifically how their application will address the public health problem as described in the CDC Background section.

ii. Outcomes Applicants must clearly identify the outcomes they expect to achieve by the end of the project period, as identified in the logic model in the Approach section of the CDC Project Description. Outcomes are the results that the program intends to achieve and usually indicate the intended direction of change (e.g., increase, decrease).

iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the project period outcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluation and Performance Measurement Plan, how these strategies will be evaluated over the course of the project period. See the Strategies and Activities section of the CDC Project Description.

1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC.

PROJECT NARRATIVE GENERAL INSTRUCTIONS (Supplemental instructions to Paragraph 10.

- "Project Narrative," above):

FORMAT:

For the application, provide one single file entitled “Activity Narratives” that includes individual and complete narratives for: General EIP Function and Structure (required), for each Core Programmatic Network Activity (includes required and optional activities), and for each Other Programmatic Activity (optional) proposed. Each individual activity narrative must include the following sections in the following order:

Background Approach

Purpose

Purpose Outcomes Strategies and Activities

Collaborations Target Populations and Inclusion

Evaluation and Performance Measurement Plan Organizational Capacity of Applicant to Implement the Approach Work Plan Human Subjects and/or Vertebrate Animal Protections (if applicable)*

See additional instructions for each of these narrative sections throughout this FOA Section D.10. and Section D.11, below.

PAGE LIMIT:

Disregard page limits stated under first sentence of Paragraph 10 - "Program Narrative," above (but do follow other page and type format instructions). Maximum number of pages for the entire Application Narrative file is 75 (excluding budget, budget narrative, appendices, and required forms). If narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

PHASING IN OF EIP ACTIVITIES (New applicants only):

For each separate activity narrative, refer to the specific activity section in Attachment 1 – Activities and respond appropriately for each narrative section. For applicants that are not current EIPs, narratives for the Core Programmatic Network Activities may reflect a phased approach that fully implements one or more of these activities over the first 2-3 years of the new EIP project period. For example, implementation of the Core Programmatic Network Activities could be staggered (e.g., implement one in year one, another in year 2, etc.) or implement multiple activities in the first year and phase or ramp up in subsequent years, or some combination.

REQUIRED ACTIVITY NARRATIVES:

Regardless whether a new applicant chooses to phase in via a phased or staggered approach, HAI/AR is required to be proposed for implementation in the first year.

Applicants that are current EIPs are required to propose full implementation/continuation of all required Core Programmatic Network Activities.

*HUMAN SUBJECTS/VERTEBRATE ANIMAL PROTECTIONS:

For each proposed activity that involves human subjects and/or vertebrate animal research, describe how applicant will ensure adherence to human subjects and/or vertebrate animal protection policies and requirements. For human subjects research, describe the risks to human subjects, the adequacy of protection against risks, potential benefits of the proposed research to human subjects and others and the importance of knowledge gained (please see Section 4.1 at: http://grants.nih.gov/grants/funding/424/SupplementalInstruct ions.pdf#4_1_protection_of_human_subject). If available, indicate the local status of IRB review or determination and provide in an attachment, copies of the most recent local IRB approvals. For vertebrate animal research, please address all required components found at: http://grants.nih.gov/grants/guide/url_r edirect.htm?id=11150 .

2. Target Populations Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities. Refer back to the Target Population section in the CDC Project Description.

In each activity narrative, clearly identify and describe the target population and catchment area for that http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf#4_1_protection_of_human_subject http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf#4_1_protection_of_human_subject http://grants.nih.gov/grants/guide/url_redirect.htm?id=11150

In each activity narrative, clearly identify and describe the target population and catchment area for that activity. Describe how the population size will be sufficient to obtain necessary data to adequately address the project objectives. As applicable and appropriate, address how specific populations who can benefit from the EIP activity will be included. For further information, see CDC Project Description section – Approach:

Inclusion, above, as well as the individual activity sections of Attachment 1.

c. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement. The Paperwork Reduction Act of 1995 (PRA): Applicants are advised that any activities involving information collections (e.g., surveys, questionnaires, applications, audits, data requests, reporting, recordkeeping and disclosure requirements) from 10 or more individuals or non-Federal entities, including State and local governmental agencies, and funded or sponsored by the Federal Government are subject to review and approval by the Office of Management and Budget. See Section E (pages 4 and 5) at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf . For further information about CDC’s requirements under PRA see http://www.hhs.gov/ ocio/policy/collection/.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant).

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Awardees will be required to submit a more detailed Evaluation and Performance Measurement plan within the first 6 months of award, as described in the Reporting Section of this FOA.

In the General EIP Function and Structure activity narrative, describe your overall strategy/structure for assuring robust overall evaluation and performance measurement capacity. In each Core Network Programmatic Activity and Other Programmatic Activity narrative, describe an evaluation and performance management plan specific to that activity. For new EIP applicants and/or for activities that are new to established EIP applicants, this may be a brief, initial plan that will be updated and more fully detailed over the first 6 months of the award.

d. Organizational Capacity of Applicants to Implement the Approach Applicant must address the organizational capacity requirements as described in the CDC Project Description.

In the General EIP Function and Structure activity narrative, clearly describe the applicant’s general capacity for implementing the EIP. Specifically describe existing or planned partnership with an academic institution as required and described earlier in this FOA. Include name of institution, name of institution PI for the EIP collaboration, institution’s capacity and experience in conducting active, population-based surveillance, laboratory testing, data management, and applied public health research, etc., as will be needed to successfully implement the EIP.

In narratives for Core Network Programmatic Activities and Other Programmatic Activities, refer to the http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf http://www.hhs.gov/ocio/policy/collection/ individual activity sections of Attachment 1 and address capacity specific to each activity as appropriate.

11. Work Plan (Included in the Project Narrative’s 20 page limit)

Applicants must prepare a…